n Patient Group Direction For The Administration Of H1N1 (Swine Flu) vaccine October 2009 PGD version template-2009.1 Page 1 of 8
Rationale Patient Group Direction For The Administration Of H1N1 (Swine flu) vaccine Registered health care professional employed by NHS City and Hackney or independent contractors within them, who has completed immunisation and vaccination training (theoretical and practical competency assessment), training in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practice update session to be undertaken) and authorised to work under PGDs. Access to the current edition of the Green Book Immunisation against Infectious Disease (2006) and any relevant updates. www.dh.gov.uk/en/policyandguidance/healthandsocialcaretopics/greenbook/dh_4097254 Qualifications Required Additional Requirements Professionals to whom these directions may apply Registered health care professional assessed as competent to work with this patient group direction Will have undertaken training in the role, care and administration of the medicine specified in the PGD. Must have access to a current copy of the BNF www.bnf.org and Immunisation against infectious disease ( Green book ) and updates and comply with its recommendations (available on DH website www.dh.gov.uk/greenbook). Must have access to all relevant DH advice, including the relevant CMO letters, or training and competent in all aspects of immunisation including contraindications and recognition and treatment of anaphylaxis. Continuing Training Requirements It is the responsibility of the individual health care professional to ensure that they are competent in all aspects of immunisation and are updated on current immunisation policy. Annual update in the recognition and treatment of anaphylaxis and basic life support is recommended. References Department of Health (2006): Immunisation Against Infectious Disease (HMSO) ( the Green Book ) and subsequent updates Department of Health: CMO Updates Summary of Product Characteristics (SmPC) for relevant vaccine PGD version template-2009.1 Page 2 of 8
ALL PATIENT GROUP DIRECTIONS WILL BE SUBJECT TO REGULAR REVIEW IN LINE WITH CURRENT CLINICAL PRACTICE YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING UNDER IT Date of overall review of this document September 2010 or in the light of significant changes in best practice PGD version template-2009.1 Page 3 of 8
Patient Group Direction for the supply/administration of to Children (6 months and over) and adults 1. Clinical Condition Define situation/condition Criteria for inclusion Criteria for exclusion Precautions Action if excluded H1N1 (Swine flu) vaccine This PGD is to be followed by all registered health care professionals, authorised to work under PGD, who carry out immunisations in hospitals, clinics, schools, surgeries, patients homes or other locations. Facilities for treating anaphylaxis must be available. Recommended for all aged 6 months and over (including breast feeding women) (Pandemrix /Celvapan ) as identified within the Green Book Influenza chapter. Children should receive the GSK vaccine Pandemrix. Pregnant women should receive the GSK vaccine Pandemrix. A confirmed anaphylactic reaction to a previous dose of the vaccine. A confirmed anaphylactic reaction to any component of the vaccine. A confirmed anaphylactic reaction to egg or chicken protein (Pandemrix only) as this vaccine is prepared in hens eggs. Children under the age of 6 months (Pandemrix /Celvapan ) Immunisation should be postponed in patients with acute febrile illness/infection. Pandemrix ( ) or Celvapan ( ) can be given at the same time as other vaccines including the seasonal influenza vaccine and other childhood vaccines. Vaccines should be given at separate sites, preferably in different limbs. Pandemrix ( ) and Celvapan ( ) vaccine products are not interchangeable, so the same vaccine product must be used if a two dose schedule is being followed. Following a full course of vaccination antibody response in immunosuppressed patients may be insufficient; therefore their household contacts should also be offered vaccination. There are clear benefits to offering to pregnant women early protection against influenza H1N1 infection. A one-dose schedule of Pandemrix ( ) should be given. There is no evidence of risk from vaccinating pregnant women, or those who are breast-feeding, with inactivated viral or bacterial vaccines or toxoids (Plotkin and Orenstein, 2004). There is no evidence of risk from thiomersal-containing vaccines to pregnant women or young children. Give further information about the vaccine or a future appointment to attend. In the case of a previous severe reaction refer to the appropriate medical officer e.g. Consultant or GP. Give information about H1N1 Influenza disease- signs and symptoms, contact number/website flu line and information on use of anti-viral medication. Action if patient declines Make patient aware of alternative, risks and potential consequences of not being vaccinated. PGD version template-2009.1 Page 4 of 8
Give advice about hand hygiene and avoiding Influenza Give information about H1N1 Influenza disease- signs and symptoms, contact number/website for concerns and information on use of anti-viral medication should H1N1 Influenza be contracted. Inform GP or refer to local policies. Document refusal in clinical records. 2. Description of treatment Name of Medicine Influenza A (H1N1) Vaccine Trade Names: Pandemrix ( ):manufactured by GlaxoSmithKline Celvapan ( ):manufactured by Baxter Healthcare POM/P/GSL POM Dose/s Pandemrix ( ): Children aged 6 months to 9 years, 0.25mls initially with a repeated dose at an interval of at least 3 weeks. Children aged 10 years and over and adults, 0.5mls. Immunocompromised individuals 10 years and over, 0.5mls initially with a repeated dose of 0.5mls at an interval of at least 3 weeks. Strength Route/Method Frequency Duration of treatment Quantity to supply Adverse effects Celvapan ( ): Adults and children aged 6 months and over, 0.5ml dose initially with a repeat dose of 0.5 ml dose at an interval of at least 3 weeks. Pandemrix ( ) :1 mixed vial contains 10 doses Celvapan ( ): 1 multi-dose vial contains 10 doses Intramuscular (Deltoid area of upper arm or anterolateral aspect of thigh) Subcutaneous route for those with bleeding disorders See above See above See above Undesirable effects for Pandemrix ( ) and Celvapan ( ) vaccines may include: Headache, fever, insomnia, dizziness, somnolence, fatigue, malaise, arthralgia, myalgia, induration, lymphadenopathy, increased sweating, shivering and influenza like illness. Referral arrangements Advice PGD version template-2009.1 Page 5 of 8 Injection site reactions such as ecchymosis, swelling, pain and redness at the site, pruritus, rash. Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea). This list is not exhaustive. Refer to current BNF and SPC for complete list. If any side effects are reported, as these are both black triangle drugs, complete & submit a report to the MHRA using the swine flu ADR portal found at www.mhra.gov.uk/swineflu.this replaces the Yellow Card system for the H1N1 Influenza vaccine only Any health professional administering a vaccination must be able to identify and contact an appropriate medical officer, e.g. CMO, consultant paediatrician, GP, as necessary, e.g. in the case of an child with an egg allergy. Give patient the patient information leaflet (PIL). Give patient
Records Follow up record card and explain patient can also directly report any suspected adverse reactions directly to the MHRA Advice on the prevention and management of fever and other common/uncommon post-vaccination adverse effects. Date of next vaccination if a two dose schedule is being followed. Give advice about hand hygiene and avoiding Influenza. Patient s name, address, date of birth and GP details; Name (brand) of vaccine, dose and form administered; Date administered; Site of injection; Manufacturer of product, batch number and expiry date; Advice given to patient; Member of staff who administered the medication; Details of any adverse drug reaction(s) and any actions taken including documentation in the patient s medical record; Serious adverse reactions should be reported to the MHRA using the Yellow Card reporting system. Arrange subsequent vaccination, if a two dose schedule is being followed. PGD version template-2009.1 Page 6 of 8
Patient Group Directions for the Administration of H1N1 (Swine flu) vaccine October 2009-September 2010 DECLARATION DECLARATION by NHS City & Hackney: This PGD has been authorised by: Enquiries relating to this PGD should be addressed to: Barbara Brese, Joint Head of Prescribing and Pharmacy, NHS City and Hackney, Primary Care Directorate, Louis Freedman Building, St Leonard s, Nuttall Street, London N1 5LZ. Tel: 020 7683 4462 Date of overall review of this document September 2010 or in the light of significant changes in best practice Signed master copy kept at tpct PGD version template-2009.1 Page 7 of 8
DECLARATION by registered healthcare professional: BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTICE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE. YOU CANNOT DELEGATE TASKS UNDER THIS PGD TO ANYONE ELSE IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT IT IS YOUR REPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION NOTE TO AUTHORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THE PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION I have been appropriately trained to understand the criteria listed and the administration procedure required to supply and/or administer drugs in accordance with this Patient Group Direction. I confirm that I am competent to undertake administration of these medications. Healthcare professional name:... Clinic/Practice/Pharmacy:........ Registration number: Expiry Date (if applicable): Signature:.... Date:. Authorising manager/lead: PGD version template-2009.1 Page 8 of 8